NCT02909257

Motor-Sparing Femoral Nerve Block Dose

Minimum Effective Concentration of Bupivacaine for Motor-Sparing Femoral Nerve Block

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Femoral nerve blocks are commonly used to provide pain control for total knee replacement, anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic concentrations result in motor block of the quadriceps and constitute an inherent risk factor for patient fall. The aim of this study is to determine the minimum effective concentration of bupivacaine in 90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the femoral nerve.

Detailed description

With the approval of Ethics Committee of the University of Chile Clinical Hospital, approximately 60 patients undergoing ACL repair or TKR will be recruited. All blocks will be conducted preoperatively in an induction room.Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design. The assignment of each subsequent concentration will be based on the response of the previous patient.As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure. The injectate will be prepared and administered by a research assistant using syringes connected to the block needle. The operator and the patient will be blinded to the concentration injected.

Conditions

• Osteoarthritis, Knee
• Knee Injuries

Interventions

Type	Name	Description
DRUG	Same Bupivacaine Concentration	patient is exposed to the same concentration than previously successful one
DRUG	Lower Bupivacaine Concentration	patient is exposed to a lower concentration than previously successful one

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-09-21
• Last updated: 2020-05-14

Locations

1 site across 1 country: Chile